Active Ingredients
Menthol...........11.3%
Earthmed Fs Pain Relieving Balm Salve
FDA Label NDC 82876-996
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earthmed Llc for the product Earthmed Fs Pain Relieving Balm (NDC 82876-996). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding, in case of an overdose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol 11.3%.........................Topical Analgesic
Menthol 11.3%.........................Topical Analgesic
Uses
Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains
Warnings
FOR EXTERNAL USE ONLY, provides penetrating pain relief
When Using This Product
Do not apply to wounds or irritated skin, and avoid contact with eyes
Stop Use And Ask A Doctor If
The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days, Rash or irritation occurs
Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days, Rash or irritations occurs
If Pregnant Or Breastfeeding
Consult a health professional before use
In Case Of An Overdose
seek medical help or contact a poison control center right away
Directions
Adults and children 12 years and over; apply to the affected area one to four times daily
Children 12 years and younger; ask a doctor
Keep Out Of Reach Of Children
keep out of reach of children
keep out of reach of children
Other Information
Store at 68-77 degrees F, Avoid direct sunlight
Inactive Ingredients
Arnica Montana oil, Arrowroot powder, Beeswax, Full Spectrum Hemp Extract, Coconut oil, Rice bran oil, Rosemary oil, and Shea butter.
* Please review the disclaimer below.
